NCT06452316 Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
| NCT ID | NCT06452316 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Claris Biotherapeutics, Inc. |
| Condition | Limbal Stem Cell Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 75 participants in total. It began in 2024-05-15 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will enroll subjects with qualifying limbal stem cell deficiency (LSCD). All subjects will receive CSB-001 investigational drug in either one or both study eyes. The study is comprised of two identical phases (Dosing Phase I and II) of test article dosing separated by a 31- to 40-day period, the Dosing Holiday, where no test article is administered. Dosing Phase II is followed by an observational, noninterventional phase (Observation Phase).
Eligibility Criteria
Inclusion Criteria: * Have an area of the central 5 mm zone of cornea affected, presence of at least one clinical sign observed by slit-lamp examination with white light and/or cobalt blue light, fluorescein, and a Wratten filter, and at least one clinical sign observed with AS-OCT. * If dosing with Acthar at time of Screening Visit, must have a history of stable dosing for approximately 8 weeks, plan to maintain the same Acthar treatment dose and regimen, and have demonstrated little to no improvement in severity of LSCD. * Sponsor written confirmation of qualifying LSCD diagnosis. * Inflammation associated with LSCD or other non-infectious inflammation that will not interfere with subject's participation. Exclusion Criteria: * Any active ocular infection (bacterial, viral, fungal, or protozoan) in either eye. * Ocular surgery within 30 days of Day 0 where investigator assesses that healing is not considered complete/stable. * Planned ocular surgery on or before Week 20 visit. * Presence or history of any ocular or systemic disorder, condition, or procedure that might hinder the efficacy of the study treatment or its evaluation, or could interfere with the interpretation of study results, in the opinion of the investigator. Note: Other inclusion/exclusion criteria apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06452316 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Limbal Stem Cell Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06452316 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06452316 currently recruiting?
Yes, NCT06452316 is actively recruiting participants. Contact the research team at clinicaltrials@clarisbio.com for enrollment information.
Where is the NCT06452316 trial being conducted?
This trial is being conducted at Loma Linda, United States, Carmel, United States, Indianapolis, United States, Minnetonka, United States and 2 additional locations.
Who is sponsoring the NCT06452316 clinical trial?
NCT06452316 is sponsored by Claris Biotherapeutics, Inc.. The trial plans to enroll 75 participants.